Mesoblast's RYONCIL Drives First Full Year of Commercial Sales as Cell Therapy Momentum Builds
Mesoblast (NASDAQ: MESO) delivered its first full year of commercial sales for RYONCIL, reporting $115 million in net revenue for fiscal 2026. The company said fourth-quarter net revenue reached $36 million, helped by the FDA-approved allogeneic mesenchymal stromal cell therapy’s continued rollout across U.S. treatment centers.
RYONCIL, cleared for children with steroid-refractory acute graft-versus-host disease, is the first and only FDA-approved mesenchymal stromal cell product in the U.S. Chief Executive Silviu Itescu told analysts on the earnings call that more than 50 treatment centers have been onboarded and insurance coverage now extends to over 98% of U.S. lives. He credited the J-code assigned in October 2025 with supporting the revenue ramp.
Chief Financial Officer Jim O’Brien said the company trimmed its net loss after tax by 44% to $57.5 million. Fiscal year-end cash stood at $103 million, with net cash usage of $43.8 million. In the second half, cash burn slowed to $13.4 million from $50 million a year earlier.
Itescu emphasized that real-world data from treated pediatric patients showed 84% early survival. The company’s immediate priorities are to increase pediatric adoption, promote earlier intervention and expand into adults with acute GVHD.
For adult GVHD, Mesoblast is enrolling a 180-patient randomized trial comparing ruxolitinib alone against ruxolitinib plus RYONCIL in grade 3 or 4 steroid-refractory disease. The study is active at more than 40 U.S. sites and is expected to take about 18 months to complete. An interim analysis could come in the fourth quarter of 2027 after roughly 100 patients are enrolled. A positive interim or full-trial result would support a supplemental biologics license application for adult label expansion.
The company also cited compassionate-use data showing 76% survival at day 100 in adolescents and adults treated with RYONCIL after failing ruxolitinib, compared with an estimated 20% to 30% survival in reports using other third-line options.
Asked about revenue expectations, Itescu declined to provide formal guidance but said the company expects double-digit growth over the next 12 months, with a clearer view emerging by mid-fiscal year.
Beyond GVHD, Mesoblast is advancing several pipeline programs. The FDA has cleared an investigational new drug application for a Phase III trial of RYONCIL in pediatric Duchenne muscular dystrophy. Itescu said the company is working with clinicians and patient groups to establish sites, noting the therapy could address early inflammation in children as young as 3 or 4 and may one day be used alongside gene therapies.
In chronic low back pain, Mesoblast completed treatment of all 350 patients in its pivotal Phase III trial of rexlemestrocel-L for chronic low back pain associated with degenerative disc disease. Top-line results are expected in the second half of calendar 2027. If successful, the company plans to file a BLA and could see approval in calendar 2028. The design aims to replicate an earlier Phase III study in which a single injection reduced pain starting at six months, peaking at 12 months and lasting at least 36 months.
Mesoblast is also pursuing FDA approval for REVASCOR, a rexlemestrocel-L program for advanced heart failure patients supported by left ventricular assist devices. A prior randomized trial showed reductions in major gastrointestinal bleeding and right-heart-failure hospitalizations, plus improved survival among higher-risk ischemic patients. The company plans to seek full approval in patients at risk of right heart failure and life-threatening bleeding, with the potential to later expand into the larger Class II and III heart failure population.
O’Brien said fiscal 2027 cash burn should be lower than fiscal 2026, supported by expected RYONCIL growth and cash receipts. He declined to specify a cash-flow-positive quarter. Mesoblast’s $125 million credit facility carries an 8% interest rate with a five-year interest-only period, preserving liquidity while the company funds Phase III programs, manufacturing and regulatory work.
Mesoblast, founded in 2004 by Silviu Itescu, describes itself as a global leader in allogeneic cellular medicines. Its pipeline is built on proprietary mesenchymal lineage cell technology, designed to modulate immune responses and promote tissue repair. The company’s other marketed product, Alofisel (darvadstrocel), is approved in Europe for complex perianal fistulas in adults with Crohn’s disease.